idarucizumab

FDA Drug Profile — Praxbind

Drug Details

Generic Name
idarucizumab
Brand Names
Praxbind
Application Number
BLA761025
Sponsor
Boehringer Ingelheim Pharmaceuticals, Inc.
NDC Codes
3
Dosage Forms
INJECTION, LIQUID
Routes
INTRAVENOUS
Active Ingredients
IDARUCIZUMAB

Indications and Usage

1 INDICATIONS AND USAGE PRAXBIND is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding PRAXBIND is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with Pradaxa ® when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding ( 1 )